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A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Compared With Placebo in Adults With Type 2 Diabetes Mellitus and Impaired Renal Function on Background Dapagliflozin

NCT07662135 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2026-08-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron, compared with placebo in adults with type 2 diabetes mellitus (T2DM) and impaired renal function, who are or will be on a background of sodium-glucose cotransporter 2 inhibitor (SGLT2i) dapagliflozin 10 mg as per guideline directed medical therapy (GDMT) for chronic kidney disease (CKD). Additionally, participants are on other glucose-lowering medication(s).

Conditions

Interventions

DRUG

Elecoglipron

Elecoglipron is administered orally once daily.

DRUG

Placebo

Placebo is administered orally once daily.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-06
Primary Completion
2028-07-13
Completion
2028-07-13
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • China
  • Denmark
  • Germany
  • India
  • Japan
  • Malaysia
  • Mexico
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07662135 on ClinicalTrials.gov